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The guidance advises registrants that reports for calendar years 2020, 2021 and 2022 “are still required under the statute and should be submitted to the Agency as soon as possible.” Read More
The FDA’s Office of Clinical Pharmacology (OCP) conducted more than 5,600 reviews of investigational new drug (IND) submissions in 2023, helping determine correct dosing for 55 new drugs and biological products. Read More
The Fifth Circuit ruling fails to recognize a long history of federal court decisions in favor of FDA’s scientific autonomy, the brief notes. Read More
The FDA did not attend a House Energy and Commerce subcommittee hearing Tuesday focused on why the agency has stalled out on its pre-pandemic efforts to improve inspections of overseas manufacturers that supply drugs to the U.S. Read More
An analysis of 10 FDA approved drug-device combinations containing GLP-1 receptor agonists found that the patents for the device portion made no mention of active drug ingredients — a requirement of FDA Orange Book listing. Read More
The FDA has finalized its 2021 draft version of a guidance that describes the timing and process of annual reporting of manufactured drugs, an effort intended to enhance the FDA’s visibility into drug supply chains. Read More
By overriding the FDA’s scientific judgments and methodology, the Fifth Circuit second-guessed the FDA’s Congressional mandate to consider all scientific evidence in drug approval decisions, the American Bar Association (ABA) wrote in its recent amicus brief on the Supreme Court’s upcoming review of the abortion drug mifepristone. Read More
A bipartisan group of six senators have released proposed reforms to the beleaguered 340B drug discount program that they claim will ensure the program fulfills its original purpose of supporting covered entities helping underserved populations. Read More
The Biden administration has sent initial offers to manufacturers of the first 10 drugs selected for drug price negotiation, saying this is the first time Medicare is not accepting the drug prices pharmaceutical companies set. Read More
Allowing courts to overturn science-driven drug approval decisions would open the door to a myriad of partisan legal challenges, exert a chilling effect on the business of drug development, and endanger patients, according to an amicus brief on the Fifth Circuit’s mifepristone restriction decision, filed by seven former FDA commissioners and acting commissioners. Read More